A study to evaluate the effects of RO7269162 on the body following oral administration in presymptomatic gene mutation carriers and non-carriers from the same kindred in Alzheimer’s Disease

A single-center, adaptive, repeated dose, phase I study to investigate the pharmacodynamics of RO7269162 following oral administration in presymptomatic carriers and in non-carriers of a genetic mutation from the same kindred in autosomal-dominant Alzheimer’s Disease

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75434529

Enrollment

Registered

2022-12-05

Start date

2024-03-11

Completion date

Unknown

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal-dominant Alzheimer’s disease Nervous System Diseases

Interventions

Cohort 1: Participants will receive RO7269162, at dose level 1, orally, for up to 7 days Cohort 2: Participants will receive RO7269162, at dose level 2, orally, for up to 7 days Follow up to day 15.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18 to 25 years of age inclusive 2. Membership in gene mutation carrier kindred. Gene mutation carrier or non-carrier status will have been confirmed prior to or during the screening period 3. Body mass index (BMI) of 18-32 kilograms per metre square (kg/m²) inclusive

Exclusion criteria

Exclusion criteria: 1. Any clinically relevant finding, condition or disease detected during the medical interview/physical examination at screening or Day -1. 2. History or evidence of any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs, including surgical history affecting gastric motility or altering the gastrointestinal tract. 3. History of convulsions 4. Participants who, in the investigator`s judgment, pose a suicidal or homicidal risk 5. Vaccination within 6 weeks prior to Day 1 including influenza and/or SARS-CoV-2/COVID-19 vaccination. 6. Positive result on human immunodeficiency virus 1 (HIV1) and HIV2, hepatitis C virus (HCV) or hepatitis B (HBV). 7. Participants who test positive for acute respiratory syndrome coronavirus 2 (SARSCoV-2) on admission to the study site

Design outcomes

Primary

Measure	Time frame
1. Time course of PD biomarkers measured using blood samples collected at multiple timepoints from baseline (Day -2) up to follow-up visit at Day 15 2. Change in PD biomarkers measured using blood samples at multiple timepoints from baseline (Day -2) up to follow-up visit at Day 15 3. Relationship between RO7269162 exposure and PD responses related to biomarkers measured using blood samples collected at multiple timepoints from baseline (Day -2) up to follow-up visit at Day 15	—

Measure

Time frame

1. Time course of PD biomarkers measured using blood samples collected at multiple timepoints from baseline (Day -2) up to follow-up visit at Day 15 2. Change in PD biomarkers measured using blood samples at multiple timepoints from baseline (Day -2) up to follow-up visit at Day 15 3. Relationship between RO7269162 exposure and PD responses related to biomarkers measured using blood samples collected at multiple timepoints from baseline (Day -2) up to follow-up visit at Day 15

—

Secondary

Measure	Time frame
1. Maximum observed plasma concentration (Cmax) of RO7269162 (and its metabolite(s) as appropriate) measured using blood samples collected at multiple timepoints on Days 1 and 7 2. Area under the plasma concentration-time curve (AUC) from zero up to 24 hours (h) (AUC0-24h) of RO7269162 (and its metabolite(s) as appropriate) measured using blood samples collected at multiple timepoints on Days 1 and 7 3. Number of participants with adverse events (AEs) and severity of AEs from signing of Informed Consent Form up to follow up visit at Day 15	—

Measure

Time frame

1. Maximum observed plasma concentration (Cmax) of RO7269162 (and its metabolite(s) as appropriate) measured using blood samples collected at multiple timepoints on Days 1 and 7 2. Area under the plasma concentration-time curve (AUC) from zero up to 24 hours (h) (AUC0-24h) of RO7269162 (and its metabolite(s) as appropriate) measured using blood samples collected at multiple timepoints on Days 1 and 7 3. Number of participants with adverse events (AEs) and severity of AEs from signing of Informed Consent Form up to follow up visit at Day 15

—

Countries

Colombia

Contacts

Public ContactClinical Trials

global-roche-genentech-trials@gene.com+1 888-662-6728

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026